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U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys Vitamin D total II

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  Class 2 Device Recall Elecsys Vitamin D total II see related information
Date Initiated by Firm April 27, 2018
Create Date July 08, 2018
Recall Status1 Terminated 3 on May 11, 2020
Recall Number Z-2389-2018
Recall Event ID 80008
510(K)Number K162840  
Product Classification System, test, vitamin d - Product Code MRG
Product Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190

Product Usage:
This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.
Code Information No specific lot codes. This issue affects users of the cobas e 801 module.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 27, 2018, the firm issued an Urgent Medical Device Correction letter to all affected customers. The letter advised customers in the following workaround to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay. The firm stated these steps are to be carried out temporarily until further information is provided: 1. Perform a thorough inspection of your pre-analytical handling to ensure a correct assay performance of Elecsys Vitamin D total II and to comply with the individual specifications of the primary tube manufacturers for all tubes in use (centrifugation conditions are particularly important as well as the elimination of foam/bubbles from the surface of the sample). 2. If the issue persists, switch from plasma to serum. 3. If you still encounter the issue for plasma or serum, re-centrifuge the sample in a secondary tube for 10 minutes at 2000 x g prior to measurement with the Elecsys Vitamin D total II assay. If you are still experiencing issues after completing the steps above, discontinue the use of the Elecsys Vitamin D Total II assay. Contact the Roche Support Network Customer Support Center at 1-800-428-2336. For the MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 analyzers, the availability of the Elecsys Vitamin D Assay (catalog number 06506780160) has been extended and may be used as an alternate method until this issue is resolved. Customers were asked to do the following: " Follow the workaround outlined in this Urgent Medical Device Correction (UMDC) to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay until further information is provided. " If none of the workaround actions listed on the previous page successfully resolve the issue, please discontinue use of the Elecsys Vitamin D total II assay and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " For all analyzers except the cobas e 801 module, the V
Quantity in Commerce 347 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRG and Original Applicant = Roche Diagnostics
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